With several COVID-19 vaccines already in phase 3 trials and investigators aiming to enroll tens of thousands of participants, Johnson & Johnson is prepping the largest study yet.
Thedrugmakeris planning to enroll a whopping 60,000 participants in a phase 3 trial set to begin next month, according to the governments clinical trialdatabase.
Thats twice theenrollment rival vaccine makersModernaand Pfizer are planning for their own phase 3 tests. Pfizer has already enrolledmore than11,000 people, according to aThursdayupdate. And Moderna signed up 8,374 participantsin the first three weeksof its own trial, CNNreportedearlier this week. But officials wereconcerned about a dearth of minorities enrolled in the Moderna trial, CNN reports.
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RELATED:Johnson & Johnson to start human testing of COVID-19 vaccine next week
Aside from those companies, AstraZeneca's vaccine is also in phase 3 testing in the U.K., Brazil and South Africa. The company has enrolled about 8,000 participants in the U.K.out of an expected 10,000,a spokesman told Politico on August 13. Investigatorshavevaccinated about 3,000 people in Brazil and 900 people in South Africa.
As for J&J, investigators plan totest the companys vaccine,Ad26.COV2.S, against placebo to see whetherthe candidate can reduce moderate to severe COVID-19. J&J expects the study to start around September 5.
These companies represent theCOVID-19 frontrunners, but many other players are involved in the hunt for a COVID-19 vaccine, including Novavax and a partnership between Sanofi and GlaxoSmithKline. Novavax isprepping a 30,000-person phase 3 trial for this fall.
RELATED:Busy AstraZeneca inks yet another big COVID-19 vaccine deal, this time with EU
As the vaccines move forward,governments around the world have been negotiating supply deals to be ready if the candidates succeed. The U.S. has inked agreements for 800 million doses, and Europe is in advanced discussions with several companiesafter signing a pact for 400 million doses with AstraZeneca.
CHICAGO - Christina Glover gets a flu shot each year and has always ensured her daughters pediatric vaccines are on schedule.
Yet the 36-year-old from the South Side of Chicago said shed be nervous about getting a COVID-19 vaccine once one emerges and hits the market.
Its the fact that its new, Glover said. You have your right to be concerned about anything - vaccines, any type of medication - you have a right to be concerned with how its going to interact with your body. ... You want to see the reaction its going to have on other people.
As scientists across the globe race to create a COVID-19 vaccine that is safe and effective, the American public appears sharply divided when it comes to the prospect of getting vaccinated against the new virus, which has so far infected roughly 5.5 million and killed more than 172,000 in the United States.
A survey earlier this week from NBC News/SurveyMonkey Weekly Tracking Poll showed that more than half of American adults either wouldnt get a COVID-19 vaccine once one is available or are unsure whether theyll get immunized. The poll found 44% said they would get the vaccine, while 22% reported they wouldnt get one and another 32% remain uncertain.
A Gallup survey earlier this month indicated that 35% of Americans would not get a free vaccine against COVID-19, if one were available and approved by the Food and Drug Administration. Another 65% responded that they would get the shot, with those identifying as Democrats far more in favor than Republicans.
Political leaders and health experts have taken up the challenge of getting the public on board, calling a future COVID-19 vaccine the key to fighting the virus and a return to normalcy. Gov. J.B. Pritzker has said Illinois wont be able to move on to phase five of the state reopening plan until a vaccine or highly effective treatment is widely available, or new cases are eliminated over a sustained period.
Chicago Mayor Lori Lightfoot earlier this month announced plans for a vaccine education initiative, fearing some residents will have reservations about getting a COVID-19 immunization.
I worry that even once we get a vaccine, that because of the speed with which its going to be brought into production, that people are going to be reluctant to take it, Lightfoot had said. So were starting now to do a lot of education about vaccines in general.
As for Glover, she said she recognizes the tension between individual health care rights versus the need to quell an international pandemic.
As a licensed practical nurse, she said she might have to get a future COVID-19 vaccine if it becomes required by her employer. And Glover said she understands the gravity of the illness: She said she contracted the coronavirus in late March. She suffered from aches, chest pains, a sore throat, shortness of breath and a loss of taste and smell through early April.
But she believes everyone should have the right to make their own medical decisions, noting that some might have religious objections or other personal concerns. While she always gets immunized to protect herself against the flu, she said she doesnt judge others who forgo the shot.
I just believe people should have a choice, they should be able to decline if they dont want to get it, she said. I understand why health care facilities would want to make it mandatory to help prevent the spread. But at the same time, to each their own. Its an individual choice.
William Taylor, 36, of the Lakeview neighborhood, said hes eager to get a coronavirus vaccine, even an early version of the vaccine if it were available to me.
I am hopeful that we could see a vaccine sooner than usual because of the serious upheaval (COVID-19) has caused and all of the resources being thrown at this, he said.
While there is no vaccine available yet, about two dozen potential COVID-19 vaccines are in various stages of testing across the globe. The Trump administration project Operation Warp Speed has dedicated billions of taxpayer dollars to fast-track a safe, effective and widely distributed vaccine against the new virus, with the goal of producing 300 million doses by January. The nations top infectious disease expert, Dr. Anthony Fauci, last month said he remained cautiously optimistic that we will have a vaccine by the end of this year and as we go into 2021.
Yet once a vaccine is available, getting the greater public on board and immunized could be the next hurdle.
I personally will not, said Lisa Casas, 54, of west suburban Itasca. The flu vaccine has been around forever and most years its not even the correct strain. I dont believe in vaccines for viruses.
While Casas has sidestepped the flu shot, she said she made sure her daughters had childhood vaccines required for school.
I believe being healthy, eating right and exercise help to fight viruses and diseases, she added. But in saying that, it should still be everyones choice as to what they do with their health.
Public health officials already have some difficulty convincing adults to get flu shots each year. A poll in late 2019 showed 37% of adults didnt plan to get the flu vaccine that season, according to research from NORC at the University of Chicago. Some reasons for forgoing the shot included concerns about side effects, a belief that the vaccine didnt work very well, the respondent reported never getting the flu and a dislike for needles, according to the survey.
Policymakers and medical experts also face opposition from anti-vaxxers, individuals and groups opposed to vaccines already on the market, whose opinions are often based on discredited research or debunked claims linking vaccines to other illnesses.
Even though no vaccine currently exists, an online petition opposing mandatory COVID-19 vaccines on the website LifeSite has garnered more than 800,000 signatures. Tens of thousands have also signed a change.org petition opposing mandatory COVID-19 vaccines in Canada.
Freedom and individual choice are main themes in both petitions.
We have managed to convince ourselves that the people whose healths are affected by a virus are much more important than the people whose lives, freedoms and livelihoods are being destroyed by this same virus, the Canadian petition reads.
Sometimes perceptions of the severity of the virus can shape vaccination views. David Cassiere, 52, of west suburban Sleepy Hollow, said he would most likely not get a COVID-19 vaccine, mostly due to concerns over possible side effects.
I would not be one of the first people lined up, he said.
He said the only way hed be convinced is if 99% or more of those immunized dont contract the virus - and even then hed likely wait at least a couple of seasons or calendar years to learn more about its safety.
Cassiere added that he fears the economic devastation caused by quarantines and stay-in-place orders more than he fears the actual virus.
I think weve erred too far restricting peoples livelihoods and commerce by quarantining everybody rather than asking people who are more at risk to do quarantining themselves, he said. Im not saying Illinois is wrong and Wisconsin is right - but I think there are other states that might be more in the middle, that are closer to having it right.
Like Cassiere, some Chicago-area residents who expressed reluctance to get vaccinated against COVID-19 were concerned about possible side effects; others worried about contracting the coronavirus from the shot, even though most of the leading vaccine candidates currently being tested dont contain a live virus and wouldnt cause infection.
Public uncertainty about whether to get a vaccine that hasnt even been developed doesnt surprise Dr. Kelly Michelson, professor of pediatrics and director of the Center for Bioethics and Medical Humanities at Northwestern University Feinberg School of Medicine.
First of all, and I think importantly, there is no vaccine now, said Michelson, who is also an attending physician at Ann and Robert H. Lurie Childrens Hospital. We dont really have the relevant information. Is it an effective vaccine? How effective is it? ... So it doesnt surprise me that people are unwilling to commit to taking a vaccine they know nothing about.
Once more is known about a future coronavirus vaccine, communication between patients and clinicians will play an important role, Michelson said.
She says good information and an open dialogue can often allay the concerns of patients who have questions about existing vaccines that have been around for years, with proven records of safety and effectiveness.
The vaccines that we have on the market that are currently tested, we have a good amount of information about, and I can say with certainty that people should get their flu vaccines, that its good for them, she said. If we do have a coronavirus vaccine, its going to be very important for clinicians - and for the public - to have good information about what it is.
Michael Barrett, 70, of northwest Indiana, said he looks forward to the day when a COVID-19 vaccine is widely available.
I would have no problem with it, even with limited trials, said Barrett, who was born and raised in Chicago but now lives in the Chesterton, Indiana, area. Weve got way more to gain at our age than to not try it. Its crazy not to. Hopefully if everyone gets it, life can go back to normal.
Hes concerned that some parts of the country are reopening too quickly, spurring outbreaks of the virus. Even as governments are loosening regulations, he believes that many retirees and individuals with underlying health conditions will continue to be worried about venturing out, further hampering the economy.
He wants to go out to dinner with family and friends. He and his wife long to travel again.
We so much miss that life we had before the virus, he said.
Public health experts in San Diego and Mexico caution that the best way to control COVID-19 long-term is with a safe, effective vaccine available on both sides of the U.S.-Mexico border.
The U.S. government has inked deals with leading vaccine developers in a bid to deliver 300 million doses of a COVID-19 vaccine by January 2021. But its going to take a global approach to quell the worst pandemic the world has faced in a century, says Steffanie Strathdee, UC San Diegos associate dean of global health sciences.
Were going to need to make sure that we dont leave segments of our population behind. We have a shared population in the border region, said Strathdee, who has studied public health at the U.S.-Mexico border for more than 15 years.
We cant just think that we need a shot for every American and that will take care of it.
Tens of thousands of people cross the U.S.-Mexico border at San Ysidro every day for work, tourism and to visit family.
Thats slowed a bit since both countries banned nonessential travel in March. But theres still plenty of traffic at the border, and travelers in both directions could carry the coronavirus, even if they feel fine.
San Diego County recently opened a free, voluntary COVID-19 testing site outside San Ysidros PedEast crossing. But by the time someone gets a positive test result back, they could have already infected family, friends or coworkers.
The best way to tamp down on transmission would be to have nearly everyone on both sides of the border vaccinated, says Dr. Andrs Smith, medical director of emergency services at Sharp Chula Vista Medical Center.
Whatever happens on one side is going to affect the other, said Smith, president of the board of directors for Cruz Roja de Tijuana. Both countries, by doing the vaccination, are going to faster control the spread.
During the 2009 swine flu pandemic, San Diego County set up vaccination clinics along the border for those entering the U.S., according to county public health officer Dr. Wilma Wooten.
More than likely, once vaccines are available for COVID-19, we will have stations there to do the same thing, said Wooten during an Aug. 14 press briefing.
But a study led by researchers at the Centers for Disease Control and Prevention showed that, of a sample of nearly 560 people who crossed the border in early 2010, only about one in four had been vaccinated.
About half of study participants entered the U.S. through the San Ysidro port of entry. The most common reasons people cited for not getting a vaccine were time constraints and their belief that they were unlikely to get infected.
The virus that causes COVID-19, however, is not the flu. The coronavirus is deadlier and more contagious than influenza, and researchers are just beginning to understand COVID-19s lingering effects in patients whose bodies have cleared the virus.
Thats made some people open to receiving a COVID-19 vaccine if one were available.
Erica Gomez, who lives in Tijuana and used to work in San Ysidro, is one of them. She crossed the border by foot to pick up an unemployment check and got tested for the coronavirus at PedEast.
Gomez said she is willing to make the trek again once a vaccine is available.
I would definitely get one, she said. But first, I want to see if there are any side effects.
According to a recent poll, roughly one in three Americans would not take a free COVID-19 vaccine approved by the Food and Drug Administration. Vaccine skepticism doesnt pose nearly as much of a problem in Mexico, said Dr. Carlos Magis, professor of public health at the National Autonomous University of Mexico.
Mexico has a very good vaccination program, Magis said. We are not charging. We are doing vaccination in the street. We are going to the houses of people.
Instead, the main challenge could be access.
Theres precedent for such concerns. Mexico was one of the first countries hit by swine flu but didnt get access to a vaccine until after the United States and Europe.
The country is trying to ensure that doesnt happen again.
Mexico and Argentina recently announced a deal with AstraZeneca to produce and distribute 150 to 250 million doses of the British Pharma giants COVID-19 vaccine throughout Latin America if it proves effective in clinical trials. Manufacturing could start as soon as early 2021, said Sylvia Varela, head of AstraZeneca Mexico. During an Aug. 13 press briefing, President Andrs Manuel Lpez Obrador assured that the vaccine would be provided at no cost to all Mexicans.
But Mexico is still moving forward with backup plans just in case.
Researchers (from left to right) Manuel Alejandro Carballo, Julio Enrique Valencia and Manuel Aguilar Yaez, working at the UABC Faculty of Science laboratory
(Courtesy photo)
Researchers at the Autonomous University of Baja California in Ensenada are participating in one of Mexicos four ongoing COVID-19 vaccine projects.
The team recently designed their candidate vaccine and are conducting preliminary studies in mice in collaboration with the University of California San Diego.
We had some concern that in Mexico, as has happened before, there would not be a supply of vaccines, said Jos Manuel Aguilar Yez, leader of the Jonas Salk Initiative, a social non-profit currently developing one of the vaccines.
Both Mexican officials and a spokesman with the Jonas Salk Initiative confirmed recently that the vaccine projects continue despite the announced deal with AstraZeneca.
When a vaccine becomes available for COVID-19, who gets it first?
Thats the latest question VPRs people-powered journalism project, Brave Little State, has set out to answer. It was asked by a Vermonter named Roger Stone. And no, hes not that Roger Stone. Although this Roger Stone says he did used to get phone calls for the other guy, when they both lived in Manhattan.
Anyway, this Roger Stone is retired from the advertising industry.
Oh, quite retired, he tells me. I'm 79 years old, and right there in the prime age group for having some bad things happen to you if you happen to contract COVID.
Stone lives in in Bondville, a tiny village in the small town of Winhall. And he says theres no Instacart where he lives. No for-profit delivery services. Not for food, not for meds. And, he says, policymakers havent done much to help older folks like him stay safe at home.
So when he heard the feds were starting to discuss how a vaccine shouldbe distributed? Stone tuned in.
And realized that it's really a question, he says. It's just like, not a slam dunk that the old people would get a high priority right behind health care workers and essential workers.
That had him worried. Worried enough to write in to Brave Little State:
What's on my mind is how the state is going to set priorities for the vaccines when they become available," Stone says. How is this going to be settled out? Is there a committee? Is there a governor? How does that work?
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Alrighty. Lets get up to speed on the global effort to get a vaccine for COVID-19 to folks like you and me.
According to a handy guide published by the New York Times, a number of teams began work on vaccines about eight months ago, in January. After testing on mice and monkeys, the first safety trials began in a small group of humans in March.
As of mid-August, there are more than 165 vaccines in various stages of development. About 30 are in human trials. Eight are in Phase 3 trials, being tested on tens of thousands of people for safety and effectiveness. Two have already been approved for limited use.
More from VPR: Confused About Antibodies? Let Our Comic (Featuring Many Llamas) Explain
And the federal government has been funding mass production of a number of vaccines. Optimists say one or more vaccines could be available to the public by the end of the year.
Others say sometime next year is more realistic. Thats really TBD. But whenever it is available, there probably wont be enough for everyone, not right away. As for who will get access first? Roger Stone, and other older Vermonters ? They arent the only ones who wanna know.
Heidi Hopper, who works as a paraeducator in South Burlingtons elementary schools, hopes to get vaccinated sooner rather than later.
I last year was diagnosed with non-Hodgkins Lymphoma, she says. Im hoping that I would be on that list coming from cancer, and working in schools.
And although her treatment went well, and she is now one year cancer free, chemotherapy damages the immune system. This semester, while Hoppers colleagues plan to be back in schools teaching in person, shell work from home.
I would love to be back in school with people, Hopper says. You know, I'm a people-person, so it will be very hard for me if I don't get the vaccine and I'm home.
Neither Hopper nor Stone think they should be first in line. In fact, almost everyone I talked to agreed those vaccines should be reserved for frontline health care workers.
But after that if there really is a shortage who is next? Other essential workers? Vermonts elders? People with suppressed immune systems? What about people of color? In Vermont, Black people have gotten COVID-19 at 11 times the rate of white people.
Giving priority to high-risk populations in this case would involve looking at racially diverse communities, based on the very worrying racial disparity that we have.
More from VPR: Race, COVID-19 And Health Disparities In Vermont
Maria Mercedes Avila is an associate professor of pediatrics and the health equity liaison at the Larner College of Medicine at UVM. She joins a chorus of medical professionals who say some racial minorities should also get priority access.
Children under nine who tested positive for COVID-19, of those children, 68% are children who are racially diverse, Avila says. That's a very alarming statistic for the second whitest state in the country.
Indeed. So many groups have valid reasons to want to be near the front of the COVID-vaccine line.
Christine Finley, the immunization program manager at Vermonts Health Department, is pretty familiar with the vaccine distribution process. Shes one of 31 liaisons to the Centers for Disease Controls standing Committee on Immunization Practices -- or ACIP. Its the group that writes federal guidelines for vaccines.
Finley represents immunization managers across the country, alongside the American Academy of Pediatrics, Academy of Family Physicians, the Association of State and Territorial Health Officers, U.S. Department of Veteran Affairs, Indian Health Service and more.
Those liaisons and 15 voting members -- almost all are doctors -- break out into more than dozen work groups to look at all aspects of vaccines: their safety, their efficacy, who should get it, when. The committee then writes and votes on vaccine guidance, which it sends to the CDC.
And that's the guidance that is expected to be followed by all health care providers, Finley says.
So is any of this process different for COVID-19? Short answer: Yes.
Everything's different for COVID, Finley says with a laugh.
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For one, Finleys group has been meeting monthly, online, rather than the usual three times a year in Atlanta.And, she says, the information is coming from vaccine researchers with a speed thats all together new.
But most different is that this time, theres a second group doing similar work at the National Academies of Science, Engineering and Medicine. They are focusing especially on issues of equity.
And somehow, by October, Finley says, these two groups hope to issue federal guidance.
After that, whenever the vaccine is available, the federal government will pay for and distribute it to each jurisdiction based on population size and other factors. Thats according to the CDC.
Once that happens, itll be up to people like Christine Finley to figure out how to get the right number of doses to the people at the top of the list.
Whoever those people are, many will likely be getting vaccine doses from UVM Medical Center, Vermonts largest medical provider and the largest employer in the state.
Among those employees is Tim Lahey, a vaccine researcher and the medical centers director of ethics. He says hospital leadership has asked the state to convene stakeholders to discuss vaccine access.
I know that conversations about the fair distribution of the vaccine are already starting, he says.
I wondered about the motivation whether UVM Medical Center was being very attentive to health care workers safety, or if it was more about them having to deal with the public, and therefore wanting some guidance?
Laheys answer: Yes.
He says hospitals dont have to deal with scarcity that often. And there will a lot of scrutiny around vaccine distribution. Hospital officials dont want to be the only ones involved.
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Lahey, of course, is trained in medical ethics -- he understands as well as anyone the challenges facing the committee members writing the vaccine guidance. And, in his mind, vaccines are different from organ transplants or ventilators. He says you cant just think about who is most at risk of dying.
Because if we found out that you can't contain the epidemic without vaccinating people in their 20s and 30s who are perfectly healthy, then we have to prioritize those people, because the point is to save lives, he tells me.
And then Lahey brings up another complicating factor, which actually works against older people like Roger Stone and immunocompromised people like Heidi Hopper:
Almost all vaccines have less effective responses from people who are immune compromised and elderly, Lahey says. So you get into this interesting conundrum where elderly people need protection from influenza the most. They need protection from COVID-19 the most. But they're also less likely to have a great response to the vaccine. And so the ideal population-level response probably is a combination of giving it to people who are most at high risk and giving it to people who are most likely to respond.
This was news to me. And this concept of prioritizing at the population level, rather than the individual? Lahey says its one reason certain racial minorities should get prioritized for vaccine.
He says thats different, however, when youre talking about ventilators.At 2 a.m. when two people are vying for one ventilator, you really cant know which of those people has suffered more injustice.
Vaccination is different. We know that race is a marker of risk of severe COVID-19, Lahey says.And we want to distribute the vaccine preferentially to people who are most at risk so that we can save the most lives possible. And vaccination is a population-level intervention.
Ideally, he says, there will be enough vaccine for everyone to access ASAP. That is still a possibility. But if there isnt, its not really up to UVM Medical Center to decide who gets priority. Its up to the CDC and the National Academies of Science, and their committees who are in the midst of eternal video conferences, hashing all this out.
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Not everybody wants to go first
But wait. All of this concern about who gets the vaccine first? Its premise is an assumption. One I didnt think much about until I talked to Linda Goodman.
I have a rare blood cancer called Waldenstrom's, it's a non-Hodgkin's lymphoma, she tells me.
Goodman is in the same support group as Heidi Hopper, the cancer survivor who works in elementary schools. Only Goodman is not gunning to be first in line for a COVID-19 vaccine.
Its an interesting question that you ask, Goodman says. The question is, who is it safe for, more than who should have priority? And when the vaccine came out, I would not get it initially until it'd been out for X period of time, so I knew what the side effects would be.
Goodman was open to the vaccine until she heard a segment on a SiriusXM radio station called Doctor Radio. Thats where she learned that even though the vaccines are going through the traditional Phase 3 30,000 person clinical trials, very rare side effects, or those affecting very small segments of the population, may not be understood until hundreds of thousands of people have received the vaccine.
And because of her cancer, Goodman says -- she doesnt want to go first. Plus, she says, shes lucky.
I have this amazing home that looks out into many, many acres, including water, she said.
And Goodman has a husband who does the shopping, and keeps her company. Shes willing to be cloistered away.
But what she brought up this fear that the vaccine wont be safe? Its more prevalent than I had understood. And its more prevalent than doctors and public health officials like Christine Finleywould like.
They named the whole piece about the vaccine on the federal level, Operation Warp Speed, Finley says. I don't think there could be a worse name that you could name something.
She adds: Because I think that it just says, Oh, gosh, they're really rushing it. And it misses what's going on. In the trials that they're doing, the standard is that you want 30,000 people in those trials. They are going to have 30,000 people. They are not cutting the size of the population that is going to be in the trials.
Finlay also notes that in a poll done by the Associated Press and University of Chicago, only half of American adults said they would definitely get a COVID-19 vaccine when it comes out.
We need to do better than that if we want to achieve herd immunity, Finley says.
As a liaison to the CDC working group, Finley is watching the sausage get made. And, she says, its made her confident the vaccine will be safe.
In the meantime, she and the committees figuring all this out are left with two contradictory but equally important mandates: Figure out how to save the most lives with a small amount of vaccine, and then convince people to come and get it.
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Thanks to Roger Stone for the great question.
If you have a question about COVID in Vermont, or anything else, ask it at bravelittlestate.org. While youre there you can sign up for our newsletter, and vote on the question you want us to tackle next. Were on Instagram and Twitter @bravestatevt.
This episode was produced by Emily Corwin, with editing from Mark Davis.
Brave Little State is a production of Vermont Public Radio. Our digital producer is Elodie Reed, and we have engineering support from Chris Albertine. Ty Gibbons composed our theme music; other music by Blue Dot Sessions.
Despite all the urgency, scientific advances and funding, there are many hurdles. In addition to the difficulty of creating and evaluating vaccines at an accelerated pace, countries must figure out how to manufacture, store and distribute hundreds of millions of doses as well as convince enough people to be vaccinated to halt the spread of the disease.
Yale School of Medicine and Yale New Haven Hospital today announced the start of Phase 3 of the Pfizer vaccine trial at the hospital. This groundbreaking study is intended to be one of several vaccine trials to be undertaken in the hopes of finding the most scientifically validated vaccine in the shortest amount of time.
The study is a collaboration between BioNTech SE and Pfizer using modified RNA. This is a novel way to create a vaccine for use in humans. Rather than using the part or whole of the actual virus in an inactive form to create immunity, this vaccine candidate uses a genetic code (modified RNA) to make the body generate proteins that resemble the SARS CoV-2 virus spike protein, thereby causing development of antibodies against it. Antibodies against the spike protein, a projection from the COVID virus that allows it to attack cells and infect a person, may block the infection from taking hold if the body comes in contact with the virus. In Phases 1 and 2 of the trial, this novel vaccine has proven safe and effective in generating an appropriate immune response. This third phase hopes to show that it can prevent infection.
I am very excited that Yale New Haven Hospital and the Yale Center for Clinical Investigation (YCCI) are undertaking this novel vaccine trial, said Principal Investigator Dr. Onyema E. Ogbuagu, YNHH Infectious Disease physician and associate professor of Medicine at Yale School of Medicine. The earlier trial phases have been very encouraging showing that when injected, the vaccine is tolerated well and generates the appropriate immune response that has the potential to protect humans from COVID-19.
The YCCI Cultural Ambassadors program is playing a large role in educating the public on clinical trials, building on past success to address cultural and operational issues to encourage a diverse and underserved patient population to participate. The Cultural Ambassador program is a partnership between YCCI, the Connecticut AME Zion Churches, and Junta for Progressive Action. Created 10 years ago, this group has had great success in engaging populations of color in clinical research. When we started talking about clinical trials in our community, people of color represented only 3%6% of the participants in clinical trials, said the Rev. Elvin Clayton, pastor, Walters Memorial AME Zion Church. Now we see between 30%-50% participation, and in some trials, over 80%.
The Cultural Ambassadors are now sharing information about the Pfizer COVID vaccine trial with the goal of ensuring that the final vaccine will be effective for everyone, regardless of their cultural or ethnic background. Our community has been disproportionately impacted by COVID-19, said the Rev. Dr. Leroy Perry, pastor of St. Stephens AME Zion Church. We will be working harder than ever to ensure that the underserved community has access to this clinical trial and when ready, the vaccine will be made affordable to those who are disproportionately affected.
The trial is a randomized placebo-controlled trial which means that of the planned nearly 30,000 enrollees, half will receive the vaccine and half will receive a placebo. If success is seen early on in the trial, all participants will be given the vaccine and all enrollees will be followed for two years. All participants must be healthy, willing to comply with scheduled visits and be between the ages of 18 and 85 years. To learn more about the trial or to sign up to participate, visit the Clinical Trials at Yale website.
This vaccine trial is yet another example of the importance of academic medical centers, said Dr. Thomas Balcezak, executive vice president and chief clinical officer, Yale New Haven Health. Our partnership with the Yale School of Medicine and YCCI creates opportunity to bring cutting-edge care and therapeutics to our community.
This vaccine is being developed at a record rate due to the rapid proliferation of COVID-19 around the globe. But despite the pace, there will be no sacrifice to safety, which is forefront in the minds of the research team, YNHH and YCCI. Prior to COVID-19, the fastest development of a vaccine was to inoculate against the mumps, which took four years.
The scale of the unmet need created by COVID-19 has been clear for months. With the virus killing people and throttling economies around the world, governments have been desperate for a vaccine. What has been less clear is the magnitude of the near-term commercial opportunity.
That has begun to change as the US government has published details of its contracts with many of the leading developers of COVID-19 vaccines. Armed with that information, Gal calculated the near-term financial opportunity in a note to investors.
Gal thinks the initial wave of vaccinations needed to start bringing the virus under control may generate revenues of around $20 billion. The estimate assumes the US will pay a slight premium to other developed markets.
What happens beyond 2021 is less clear. At this stage, it is unclear how long immunity conferred by the vaccines will last. If annual booster shots are needed, vaccine manufacturers could continue to generate sizable sales for years to come, particularly if they are able to charge governments prices that more accurately reflect the value of their products after the pandemic ends.
For now, the focus is on showing the vaccines work and scaling up manufacturing to quickly meet the current pent-up demand. Based on company disclosures, Gal expects vaccine manufacturers to have enough capacity to meet demand in the developed world.
Gal modeled that AstraZeneca, Johnson & Johnson, Moderna, Novavax, Pfizer, and Sanofi, the six big vaccine developers covered in the analysis, have capacity to supply more than 5 billion doses.
How soon those products get to governments depends on when the vaccines get regulatory approval and the speed at which manufacturing ramps up.
Gals model has three vaccine developers Pfizer, Moderna, and AstraZeneca shipping products this year. Those companies are predicted to ship enough products to vaccinate 158 million people by the end of the year.
The big vaccination push will come early in 2021. Gal predicts J&J, Novavax and Sanofi will start shipping vaccines in the first quarter. With the first three vaccine manufacturers to market continuing to ship products, Gal predicts the authorization of the new candidates will give countries the capacity to immunize 709 million people by the end of March.
If accurate, the forecast suggests developed countries could have enough vaccines to immunize their populations by the end of the first quarter. There are around 1.1 billion people in the US, Canada, the UK, the European Union, Japan and Korea, the developed markets Gal expects to buy up most of the first vaccines.
That forecast is underpinned by the expectation that manufacturers, particularly J&J and Sanofi, will make big volumes of vaccines before winning approval. Gal expects J&J and Sanofi to each distribute enough vaccines to immunize 100 million people in their first month on the market.
Im a vaccine lover. I got the shingles vaccine as soon as a colleague had a gruesome experience with an itchy, painful rash. But the prospect of a vaccine for COVID-19 has been scaring me. On the positive side, scientists are dropping everything and rushing to create a vaccine; whoever succeeds will be the worlds savior. On the other hand, the word rushing is a little unsettling.
How do you know its safe? How do you know you should get it? Globally, 31 vaccines are in human trials, and many more candidates are being studied. Russia has already approved a vaccine but it skipped the phase where it is subjected to large-scale testing, raising skepticism in the global medical community.
A surprising number of Americans have expressed concerns about this process to polltakers, with as much as half the population saying they might not take a vaccine, either because theyre against vaccines in general or because they dont trust Trumps government and worry he will pressure the FDA to approve vaccines quickly for political reasons.
So, whats worse: risking the vaccine, or risking the illness and its potentially debilitating long-term repercussions (not to mention death)?
For guidance, I turned to James R. Baker Jr., a professor at the University of Michigan who researches immunology. He holds 50 patents, has testified before Congress many times, founded four companies, and served as global head of vaccines for the big drug company Merck. He also writes the very informative blog, Pandemic Pondering.
Here is a condensed, edited version of a conversation that surprised me in its bluntness.
Q: Will there be multiple vaccines, and will we get to choose which ones seem best for us?
A: Even if one is approved, work will continue on others. The early vaccine candidates are being developed predominantly in younger, healthier people with an age cutoff of 55.
Q: What do you mean? Theres an age cutoff?
A: They are not testing them in older people. And that is a huge problem. Basically the people that really need this vaccine are over 50.
Q: Why are so many companies not testing older people?
A: The real reason they want to test younger people is they know they will respond better and they are more likely to get an immune response that will lead to approval.
The World Health Organization (WHO) on Tuesday urged countries to join a global pact aimed at ensuring less wealthy countries have access to COVID-19 vaccines, warning about the risks from so-called vaccine nationalism. Here is a look at the WHOs plan and the approaches by wealthier nations.
COVAX is working to ensure fair access to COVID-19 vaccines.
Image: Reuters/Dado Ruvic/Illustration
What is the WHOs vaccine program?
The COVAX global vaccines facility is a program designed to pool funds from wealthier countries and nonprofits to develop a COVID-19 vaccine and distribute it equitably around the world. Its aim is to deliver 2 billion doses of effective, approved COVID-19 vaccines by the end of 2021.
The details of the program are still being hashed out ahead of an Aug. 31 deadline for nations to join. It is led by the WHO, along with the Gavi vaccine alliance, and the Coalition for Epidemic Preparedness Innovations (CEPI).
COVAX is part of a broader program, called the Access to COVID-19 Tools (ACT) Accelerator, that works to ensure that vaccines, treatments, diagnostic tests and other healthcare resources are broadly available to combat the pandemic.
What are the wealthier nations doing?
They have focused on securing vaccines for their own citizens, striking deals for the first doses even as data has yet to prove the vaccines to be effective.
Governments including United States, the United Kingdom, Japan, and the European Union have spent tens of billions of dollars on deals with vaccine makers such as Pfizer Inc (PFE.N), Johnson & Johnson (JNJ.N), AstraZeneca Plc (AZN.L) and others. The United States alone has committed nearly $11 billion for development, testing, manufacture and stockpiling of hundreds of millions of doses.
Russia and China are also working on vaccines and have already begun vaccinating some of their citizens.
What kind of resources are being brought to bear?
The ACT Accelerator is financed by a variety of nonprofits and governments. It is aiming to raise about $31 billion.
So far, the COVAX facility has attracted interest from 92 poorer countries hoping for voluntary donations and 80 wealthier countries, a number little changed from a month ago, that would finance the scheme, according to the WHO.
What is the WHO's concern?
The WHO has expressed concern that wealthier countries hoarding vaccines for their own citizens could impede efforts to end the pandemic.
We need to prevent vaccine nationalism, WHO chief Tedros Adhanom Ghebreyesus said during a Tuesday virtual briefing. Sharing finite supplies strategically and globally is actually in each countrys national interest.
WHO leaders have said that developing a coordinated global distribution system for COVID-19 vaccines that prioritize those at greatest risk of getting sick, such as healthcare workers, would help curb the spread of coronavirus worldwide.
Approving a vaccine in the U.S. usually takes years, but COVID-19 vaccines are moving through in record time. What does that mean? USA TODAY
Operation Warp Speed the White House-led partnership for COVID-19 answers is pushing its partners to be ready to begin distributing acoronavirus vaccine by Nov. 1.
The date is the first concrete goal set for companies working with Operation Warp Speed be prepared to deliver vaccines to doctors and hospitals, said Wes Wheeler of thedeliverygiant United Parcel Service.
Wheeler said UPS and other partners will be conducting test delivery runs in September. Well be ready. We have to be ready," he said."The world is watching. We cant fail."
Operation Warp Speed is comprised of federal agencies such as the CDC, the FDA and the Department of Agriculture. The initiative aims to expedite the rapid production of COVID-19 tests, treatments and vaccines. Its goal is to produce and deliver 300 million doses of vaccine by January.
UPS is working as a consultant to Operation Warp Speed, Wheeler said. As the process moves forward, it expects to beinvolved with the governmentand private drug manufacturers in the logistics of vaccine distribution and storage in some capacity.
The Nov. 1 distributiondate is significant because President Donald Trump has repeatedly said he expects a vaccine to be released very soon. There has been speculation he might launch an "October Surprise," counting on the release of a coronavirus vaccine to buoy his chances at the ballot box on Nov. 3.
The Food and Drug Administration and other top government scientists have said only science and data will be taken into account when deciding if a vaccine is accepted. On Thursday, Peter Marks, the director of FDA'sCenter for Biologics Evaluation and Research, told Reuters he has faced no political pressure to release a vaccine without sufficient data onsafety and effectiveness and he would resign if that happened.
The FDA has said it might consider releasingat least the first vaccine under what's known as an Emergency Use Authorization rather than the full licensing process, if it has sufficient data on safety and efficacy.
"We have to balance the need to see a biologics license application ... (it has) thousands of pages with a lot of different analyses many of which will not be directly relevant for a decision of whether or not to make the vaccine available," Marks told a group of journalists attending a National Press Foundation training on Aug. 13.
No one can say with certainty when a SARS-CoV-2 vaccine will be approved for use by the FDA because its not known when the results of the large Phase 3 clinical trials will be available, or whether those results will meet the agency's requirements for safety and effectiveness, said Dr. Kelly Moore, associate director of immunization education and the Immunization Action Coalition.
Nonetheless, those preparing to distribute a SARS-CoV-2 vaccine are aiming to be ready to begin distribution as soon as a vaccine is approved, said Moore, who also is a professor of health policy at the Vanderbilt School of Medicine in Nashville, Tennessee.
The logistics are daunting. The U.S. government is currently investing in at least seven potential vaccines. At least one of themneeds to be stored and transported at-80 degreesCelsius or -112 degreesFahrenheit, a temperature at which antifreeze freezes and rubber shatters. Three others have to be stored at-20 degreesCelsius or -4degreesFahrenheit, the temperature ice cream is shipped at.
The candidate vaccines already are being produced and stored at manufacturing sites across the country. If they prove safe and effective, and are approved by the FDA, they will be released for use. Any candidate vaccines that dont will be destroyed.
Delivery of the vaccine to sites where it can be administered will happen in two waves, an early one, when supplies are limited and the military will be involved in logistics, and a later one, when the vaccine is plentiful and can be distributed through the regular vaccination channels.
That plan is that in phase 1 we will have 10 million doses distributed in November and 20 million doses in December, said Wheeler, president of UPS Healthcare.
Because the initial doses will be in limited supply, the focus is expected to be on getting high priority recipients likely front line health workers fully vaccinated first, said Moore.
I get the sense the Centers for Disease Control, the Department of Defense and the states will target a limited number of locations where they can easily reach people determined to be top priority, she said.
Once more vaccine becomes available, likely within several months, the second wave of distribution would go through the routine vaccine distribution program, probably using the existing national Vaccines for Childrenprogram as a backbone, she said.
Thats also when vaccinations would likely become available at major pharmaceutical chains such as Walgreens and CVS. Both companies are already planning for that, they told USA TODAY.
The logistical situation is remarkably complex because there are multiple items involved.
Experts presume more than one vaccine may be ready early on, meaning there could be one, two or as many as seven different vaccines being administered nationally at the same time, each with a different temperature storage requirement.
Its also thought some vaccines might work better for one group and others for another. Thats an enormous transportation complication, said Wheeler.
Theyre going to try to match effect with patient population," he said."So if one of the vaccines looks as if it will work best with young, healthy people then you divert to that population, if another works better with the elderly then it would go to that population specifically.
Operation Warp Speed also wants the doses shipped with a matching vaccination kit containingpersonal protective equipment for the person giving the shot andleaflets about that particular vaccine, Wheeler said.
In 30 years in the drug business, Ive never seen anything like this. The logistics are amazing, he said.
The vaccine, when it comes, will be more precious than gold. UPS already is involved in distributing doses of several of the candidate vaccines now being tested in Phase 3 clinical trials, in which 30,000 volunteers are given either a candidate vaccine or a placebo shot.
There is not one single vial to spare, not one. We have 24/7 GPS tracking on every shipment, he said.
As it gears up for the work, UPS is already building a freezer farm at its Louisville, Kentucky, air operations headquarters, as well as a COVID-specific operations center there. The freezer farm building will be filled with hundreds of ultra-low temperature freezers, each about the size of a large home refrigerator but which can hold materials as low as -85degreesCelsius.
About half the freezers are already in place and theyre being validated now, he said.
The company has similar freezer farms in the Netherlands at its international air transit hub.
An ultra-cold freezer that can store items at as low as -80 Celsius/-112 Fahrenheit, at UPS' cold storage facility in Venlo, The Netherlands.(Photo: UPS)
Vaccinethatmust be kept at -80 degreesCelsiuswill be transported in boxes topped off with dry ice, which can be replenished as the dry ice boils away, Wheeler said.
Air transportation requires another level of planning at these temperatures because there are limits on the amount of dry ice that can be loaded onto planes under FAA regulations.As it sublimates to gaseous carbon dioxide there is a danger the oxygen content of the air would fall too low, incapacitating the crew.
Keeping vaccines at their proper temperature is crucial to keeping them effective, said Jaap Venema, chief science officer for U.S. Pharmacopeia, a public standard-setting organization for drugs.
As much of 25% of vaccine globally is lost because of cold chain issues. As the world works to create enough coronavirus vaccine for everyone, such loses are unimaginable, he said.
Thats keeping me up at night, he said.
Vaccine developer Pfizer said it hasdetailed logistical plans and tools to support transportation of its candidate vaccine, which must be kept frozen at -80 degreesCelsius.
We have specially designed, temperature-controlled containers that would allow the maintenance of storage conditions up to 10 days, said Pfizers director of media relations Steve Danehy.We are confident of our capability to deliver and store doses to the destinations governments designate, according to requirements at -80."
Contributing: Karen Weintraub
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.
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